Merck ZENITH Trial Phase 3: Evaluation of WINREVAIR™ (sotatercept-csrk)
Merck, also recognized as MSD outside of the United States and Canada, just shared exciting news about their Phase 3 ZENITH trial for WINREVAIR (sotatercept-csrk) in treating patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality. The study hit the mark of its primary goal of time to first morbidity or mortality event, including all-cause death, lung transplantation, or PAH hospitalization of at least 24 hours.
The results were so positive that the study will be stopped early, and all participants will have the chance to receive WINREVAIR moving forward. This success adds to the growing body of evidence for WINREVAIR, an activin signaling inhibitor therapy targeting the root cause of PAH.
Dr. Eliav Barr, Merck Research Laboratories’ senior vice president, and head of global clinical development noted the significance of these findings, emphasizing the potential of WINREVAIR to make a real difference in managing PAH in the future. Dr. Vallerie McLaughlin, an investigator in the trial, expressed hope sparked by WINREVAIR’s results, thanking everyone involved for their contributions.
WINREVAIR, approved in the U.S. and 36 countries, has now been submitted for approval in Japan following the positive outcomes from the Phase 3 STELLAR trial. Results from the ZENITH trial will be shared at an upcoming medical meeting and submitted to regulatory authorities for review.
The ZENITH study, a global clinical trial, assessed WINREVAIR in combination with background PAH therapy on the time to first event of all-cause death, lung transplantation, or PAH worsening-related hospitalization. The trial saw 172 participants joining, with the primary outcome being time to first confirmed morbidity or mortality event.
This exciting news sets a high standard for future studies and treatments for PAH, showcasing the potential of WINREVAIR to be a game-changer in the field.
